The
Food and Drug Administration (FDA) is seeking a $2.2 million penalty
against a hearing aid manufacturer for violations of federal law. The
violations may have exposed recipients of the devices to unnecessary
health risks.
The manufacturer, Advanced Bionics LLC,
of Sylmar, Calif., makes a hearing aid called the HiRes90k Implantable
Cochlear Stimulator, which is surgically implanted under the skin
behind the ear to treat profound hearing loss in adults and children.
The hearing aids pose a health risk due to excessive moisture, exposing people who received the devices to the risk of
-
device failure
-
possible need for surgery
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potential for additional hearing loss
FDA's
complaint, originally filed in November 2007 and amended on March 17,
2008, seeks penalties against Advanced Bionics and its president and
co-CEO, Jeffrey H. Greiner.
FDA's complaint alleges that Advanced Bionics
-
shipped
hearing aids to customers in the United States prior to filing
appropriate supplemental information with FDA, including a notice of
changes made to the devices that affected their safety and
effectiveness.
-
failed to comply with FDA's current
Good Manufacturing Practice (GMP) requirements for devices. The alleged
GMP violations include the failure to sufficiently evaluate and select
a new vendor to supply a critical device component, and the failure to
adequately test the continued safety and effectiveness of the hearing
aid when the unapproved vendor's component was used.
-
shipped
hearing aids in violation of the law between January 2005 and July
2006. Two hearing aids shipped and implanted after a March 2006 recall
contained the component from the unapproved vendor.
For More Information
Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html
Date Posted:
April 4, 2008
